Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis (StomaPed)

Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis

Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine. The traditional loop ileostomy has recently be challenged by ileostomies in continuity, either the Santulli or the Bishop-Koop one, that both decompresses the proximal dilated bowel and allow intestine fluid to pass through the underlying ileal anastomosis. Nevertheless, to date, no evaluation of their indications, complications and potential benefits has been made.

The aim of this study is to retrospectively compare the outcomes of loop ileostomies and ileostomies in continuity in a paediatric population.

It is thus expected to better define the specific indications for these different types of ileostomies in the paediatric and neonatal population.

Study Overview

• Status: Unknown
• Conditions: Enterocolitis, Necrotizing; Intestinal Obstruction; Gastroschisis; Hirschsprung Disease
• Intervention / Treatment: Procedure: Ileostomy

Detailed Description

The methodology used will be a retrospective non interventional study of the cohorts of paediatric patients having had one or more ileostomies performed in one of the surgical centers participating in this study, between 2007, january the 1st and 2019, august the 31th.

The main outcome will be the duration (days) between full refunctionalization of the bowel in the groups of conventional ileostomy or ostomy in continuity, as assessed by the end of parenteral nutrition or the closure of the stoma.

Secondary outcomes will include (1) the number and type of complications directly related to the stoma and/or to intestinal complications; (2) the comparison of the results obtained by Santulli and Bishop-Koop ileostomies; (3) a sub-group analysis of the outcomes in the different underlying pathologies.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Françoise SCHMITT, MD, PhD; Phone Number: +33241354290; Email: FrSchmitt@chu-angers.fr

Study Locations

• France
  • Brest, France, 29200
    • University Hospital of Brest
    • Contact: Philine De Vries, MD, PhD; Email: philine.devries@chu-brest.fr
  • Nantes, France, 44000
    • University Hospital of Nantes
    • Contact: Sébastien Faraj, MD; Email: sebastien.faraj@chu-nantes.fr
  • Paris, France, 75015
    • Necker Enfants malades hospital
    • Contact: Sabine Sarnacki, MD, PhD; Email: sabine.sarnacki@aphp.fr
  • Rennes, France, 35200
    • University Hospital of Rennes
    • Contact: Alexis Arnaud, MD, PhD; Email: alexis.arnaud@chu-rennes.fr
  • Tours, France, 37000
    • University Hospital of Tours
    • Contact: Itissam Kassite, MD; Email: ibtissam.kassite@univ-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newborns and children presenting with complex intestinal obstruction and requiring the use of an ileostomy to discharge the upper intestine as part of surgical care.

Description

Inclusion Criteria:

• all patient aged 16 or less having had one or more ileostomy created as part of its care for an intestinal obstruction, between 2007/01/01 and 2019/08/31. If a patient requires more than one ileostomy, each new stoma will be analysed as a new entry in the study.
• patients having been operated in one of the paediatric surgical department participating in this study.

Exclusion Criteria:

• refusal or absence on consent of the patient and/or their legal representative to participate to the study.
• patient who had an ileostomy created in another center than the ones participating in the present study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ileostomy in continuity; Paediatric patients having had an ileostomy in continuity as part of the treatment for a complex intestinal obstruction, as described by Santulli or by Bishop-Koop.	Procedure: Ileostomy; Use of an ileostomy to decompress the proximal bowel, perfored either as a conventional loop ileostomy or as described by Santulli et al. or by Bishop and Koop.; Other Names: Loop ileostomy; Santulli ileostomy; Bishop-Koop ileostomy
Conventional ileostomy; Paediatric patients having had a loop ileostomy as part of the treatment for a complex intestinal obstruction.	Procedure: Ileostomy; Use of an ileostomy to decompress the proximal bowel, perfored either as a conventional loop ileostomy or as described by Santulli et al. or by Bishop and Koop.; Other Names: Loop ileostomy; Santulli ileostomy; Bishop-Koop ileostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay before full refunctionalization of the small intestine	Mean delay before full enteral nutrition after the creation of the ileostomy, as assessed by either the end of the use of parenteral nutrition, or by closure of the ileostomy.	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical description of the sub-groups of patients with ostomy in continuity	Clinical description of the patients (underlying disease, demographics, nutritional outcomes, medical and surgical complications) having had a Santulli or a Bishop-Koop ostomy.	through study completion, an average of 6 months
Comparative analysis of the complications of ostomies	Number and type of complications encountered after loop ileostomy and after ostomy in continuity	through study completion, an average of 6 months
Subgroup analysis of the patients according to their underlying pathology	Comparative analysis of the efficacy and complication rates of the different types of stoma in subgroups of patients, according to their underlying pathology	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Publications and helpful links

General Publications

• BISHOP HC, KOOP CE. Management of meconium ileus; resection, Roux-en-Y anastomosis and ileostomy irrigation with pancreatic enzymes. Ann Surg. 1957 Mar;145(3):410-4. doi: 10.1097/00000658-195703000-00017. No abstract available.
• SANTULLI TV, BLANC WA. Congenital atresia of the intestine: pathogenesis and treatment. Ann Surg. 1961 Dec;154(6):939-48. No abstract available.
• Sehgal S, Sandler AD, Alfred Chahine A, Mohan P, Torres C. Ostomy in continuity: A novel approach for the management of children with complex short bowel syndrome. J Pediatr Surg. 2018 Oct;53(10):1989-1995. doi: 10.1016/j.jpedsurg.2018.02.059. Epub 2018 Mar 4.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: ileostomy; enteral nutrition; complications of stoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Musculoskeletal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Musculoskeletal Abnormalities; Hernia; Digestive System Abnormalities; Megacolon; Enterocolitis; Enterocolitis, Necrotizing; Gastroschisis; Hirschsprung Disease; Intestinal Obstruction
• Other Study ID Numbers: 2019/10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No